ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

Sponsor

Duke Vascular, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01033214

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm	Device: Endovascular repair of TAA in the descending Thoracic Aorta	Phase 1

Detailed Description

Subject is > 18 years of age.
Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
Subject is a candidate for endovascular thoracic aortic repair.
Subject has a TAA that meets one of the following criteria:
Is diagnosed with a Fusiform Focal TAA >5cm, or
Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or
Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
Is diagnosed with a saccular TAA of any size.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAArget Thoracic Stent Graft those treated with the investigational device	Device: Endovascular repair of TAA in the descending Thoracic Aorta Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.

Arm

Intervention/Treatment

Experimental: TAArget Thoracic Stent Graft

those treated with the investigational device

Device: Endovascular repair of TAA in the descending Thoracic Aorta

Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.

Outcome Measures

Primary Outcome Measures

Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group. [30 day and 6 month]
The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events [30 day and 6 months]

Secondary Outcome Measures

• All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events [30 day and 6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.

Subject is a candidate for endovascular thoracic aortic repair.

Subject has a TAA that meets one of the following criteria:

Is diagnosed with a Fusiform Focal TAA ≥5cm, or
Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
Is diagnosed with a saccular TAA of any size (where potential for rupture is increased*).

Tortuosity and angulation do not exceed 90 degrees.
Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.

Exclusion Criteria:

Subject has a life expectancy < 2 years.
Subject has a lesion that prevents safe delivery or expansion of the device.
Subject has concomitant ascending aortic aneurysm.
Subject has known allergies to any of the device materials.
Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.